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FDA 510(k)

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106

K-Number: K002734 · 2000-09-14

ApplicantAspect Medical Systems, Inc.
Decision Date2000-09-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-09-14 under 510(k) number K002734. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106?

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 is a medical device that received FDA 510(k) clearance on 2000-09-14. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K002734.

When did ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 receive FDA 510(k) clearance?

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 received FDA 510(k) clearance on 2000-09-14, under 510(k) number K002734.

Who is the listed applicant for ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106?

The FDA 510(k) record lists Aspect Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106?

The FDA product code for ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 is GXY.

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Official Source

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